GDUFA Research Outcomes

Human Factors

Research in this area is related to human factors and interactions with the user interface of generic drug-device combination products.

• All(19)
• Posters(2)
• Presentations(15)
• Papers(2)

• Complex Generic Drug-Device Inhalation Products and User Interface Sameness: Successful Outcomes

  Witzmann, Kimberly

• Comparative Analyses: Device and User Interface Considerations

  Witzmann, Kimberly

• Overview of Regulatory and User-Interface Considerations, and the Role of Comparative Analyses, in Developing a Generic Drug-Device Combination Product in an ANDA

  Witzmann, Kimberly

• Overcoming Barriers to Entry for Complex Generic Oral Inhalation Drug Products

  Witzmann, Kimberly

• The Role of Comparative Analyses for Evaluation of Generic Drug-Device Combinations in an ANDA

  Witzmann, Kimberly

• Approaches to Analyzing Comparative Use Human Factors Studies

  Wang, Jing

• Generic Drug-Device Combination Product Assessment

  Luke, Markham C; Berry, Karyn L; Ren, Ke

• Closing Remarks

  Lionberger, Robert

• Understand Best Practices of User Interface Assessment for Generic Drug-Device Combination Products

  Hartka, Kathryn

• Comparing Device User Interfaces and Seeking Advice in the Pre-ANDA Period

  Hartka, Kathryn